An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada.

BACKGROUND: Self testing for HIV is a targeted intervention with the potential to increase the access, uptake and frequency of HIV testing and more effectively reach the undiagnosed, especially in priority populations. The objectives of this study were to (1) evaluate the INSTI HIV self-test performance compared with laboratory reference testing, (2) document if intended users can perform the steps to use the HIV self-test device, and (3) document if intended users can successfully interpret contrived positive, negative, and invalid results. Study was intended to be submitted to Health Canada for review for regulatory approval purposes. METHODS: The study used a cross-sectional design and recruited consenting adults who were representative of intended users of HIV self-testing from four community sites across Ontario, Québec, and Manitoba between August 2019 and March 2020. The results of the observed HIV self-test were compared with results of the Abbott Architect HIV Ag/Ab Combo test. Usability outcomes for critical (e.g., lancing finger, blood droplet into bottle, shaking bottle four times) and noncritical self-test procedure steps were also determined. RESULTS: Overall, 77% (n = 522) of participants were between 18 and 45 years of age, 61% (n = 410) were male, 71% (n = 480) had some college or more education, and 45% (n = 307) were employed; identity for race and ethnicity: Caucasian (44%; n = 296), African, Caribbean or Black (17%; n = 113), Indigenous [First Nations, Métis or Inuit] (14%; n = 95), Asian (16%; n = 106), Latin American (7%; n = 46). Primary performance analysis on 678 completed HIV self-tests revealed a positive percent agreement of 100% (5/5, 95% CI: 43.6-97.0%) and a negative percent agreement of 99.5% (614/617, 95% CI: 98.6-99.8%) with the comparator method. The overall percent agreement of results interpretation between participant and observer was 93.5% (n = 633). For the 708 participants who took part in the usability study, the average success rate for steps determined to be "critical" for successful completion of the test was 92.4%. 97% (n = 670) of participants found the instructions easy to follow, and 95% (n = 655) of participants indicated that they would use the test again. Of the 404 participants who interpreted the strong positive, weak positive, negative, and invalid contrived results, successful interpretation ranged from 90.6% (for weak positive, n = 366) to 99.3% (for negative, n = 401). CONCLUSIONS: The addition of a regulatory-approved self-test into the Canadian HIV testing landscape could significantly increase HIV testing rates. Having a blood-based HIV self-test approved in Canada can offer an accurate, acceptable, and simple alternative to facility-based HIV testing, particularly when impacted by Coronavirus pandemic restrictions.

Contemporary Outcomes of Acute Coronary Syndromes in Indigenous Compared With Non-Indigenous Patients: A Northern Saskatchewan Perspective.

BACKGROUND: In patients presenting with an acute coronary syndrome (ACS), the impact of efforts to bridge historical care gaps between Indigenous and non-Indigenous patients remains limited. METHODS: For consecutive ACS presentations (ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation myocardial infarction [NSTEMI]/unstable angina [UA], respectively) at the Royal University Hospital, Saskatoon, we compared self-identified Indigenous and non-Indigenous patients' demographics, treatments, and all-cause mortality (in-hospital and within 3 years). We used propensity score inverse probability weighting to mitigate confounding and Cox regression models to estimate the adjusted hazard ratio (aHR) for all-cause mortality. RESULTS: Of 3946 ACS patients, 37.2% (n = 1468) were STEMI, of whom 11.3% (n = 166) were Indigenous. Of the NSTEMI/UA (n = 2478), 12.6% (n = 311), were Indigenous. Overall, Indigenous compared with non-Indigenous patients were likely to be younger, female, have higher risk burden, and live more remotely; Indigenous STEMI patients triaged to primary percutaneous coronary intervention had longer times from first medical contact to device, and Indigenous NSTEMI/UA patients more likely to present with heart failure, cardiac arrest, and cardiogenic shock. No significant differences were noted for in-hospital mortality (STEMI 8.4% vs 5.7% [P = 0.16], NSTEMI/UA 1.9% vs 1.6% [P = 0.68]), although in follow-up, Indigenous STEMI patients were associated with a higher all-cause mortality risk (aHR 1.98, 95% CI 1.19-3.31; P = 0.009) with no between-group differences evident for NSTEMI/UA (aHR 1.03, 95% CI 0.63 1.69; P = 0.91). CONCLUSIONS: Indigenous compared with non-Indigenous patients presenting with an ACS had higher cardiovascular risk profiles and consequent residual mortality risk. Improving primary care and intensifying secondary risk reduction, particularly for Indigenous patients, will substantially modify ACS outcomes in Saskatchewan.